Iovance Biotherapeutics Inc (IOVA) Quote

I do not think the company will give any guidance until the Corporate Update for 2025 (next Feb). I think they will only report out actual starts (thru end-April for Q1, end-July for Q2, etc) which does give some clarity for next quarters' revenue.

In regards to my estimate, since there is no new data, I have revised my starts to about 115 thru April 30. This is based on the following assumptions:
1) Linear ramp based on starts thru Feb (approximately 1.55 patient starts per ATC per month) for the 30 existing ATCs (assuming no adds from the 6 additional ATCs thru April)
2) Fred's comments upon approval and re-iteration during Cowen fireside that the 20 patients were "a tiny fraction of the bolus".
3) Build of of the iCTC for a capacity of 2,000 (165/month) plus a vendor back up because they did not want to end up in a situation similar to the CAR-T roll out where initial demand outstripped capacity.
4) ATCs investment in time and resources (200 hours for the lead physician + support staff training plus infrastructure) is a big commitment from the Cancer Centers so they would expect some demand before committing to becoming an ATC.

The Q2 analyst revenue projections are 5.2M (low), $28.6M (average) and $60.6M (high). This equates to about 10, 58 and 122 starts thru April. We are already way over the 10 thru Feb and only an additional 38 to get to the average. I am confident that we will blow away those 2 and should be closer to the top-end. I was playing that expected pop using some options, but this continued weakness may not hit those strikes even with a substantial beat.

This weakness continues to surprise me. I will probably add some additional lower strike options right before earnings if this weakness/lower level continues.

Surfkast, we're all down from the high. I wish you good luck and a nice run up soon, but this is still all about earnings going forward and the time it'll take to book those earnings IMO. The entire sector has not been our friend ever since we hit the high as did the sector funds. It's all down.

GMH, have you got any updates on your expectations for guidance regarding Q2, 3 and 4?

I think we're at 36 ATC's currently with the goal of 50 by end of May or June? Somewhere around there.

Thanks in advance.

Been retired and still up but down from the high big time here.

Right now I am pretty much all-in on the market (as I was during all of my working career). In retirement, I set up 3 years worth of expenses in a CD ladder (and can extend to 4 if I use my dividends). This will allow me to ride out most of the normal downturns. Political events are always short lived... remember Russia/Ukraine was only a 3 month market downturn and that probably has more ramifications that the Middle East.

Over the long term, a stocks fundamentals will come thru. It is just important to know why you own the stock and when that thesis no longer holds (i.e. price target met or facts change). Stock price at any given time is impacted by a lot of factors but over time, it is the stock fundamentals that matter. Buffet's voting machine vs weighing machine quote.

Surfkast, all markets are affected by uncertainty. People move to safety when things look scary, rational thought is affected by fear. The media will hype even the smallest of negative events, but imagine if the Middle East escalates. Oil goes up, many stock prices come down, fundamentals take a back seat for awhile.

Sunman knows that rebounds for the good companies will happen as certainty returns, but keeping dry powder allows us to pick up a few good companies on the cheap (or cheaper at least) during those times of uncertainty.

If you're of retirement age, there's nothing worse than a negative market sentiment when you want to sell down your positions. If you're younger, these are the times to build portfolios using sound fundamentals.

Good luck. Sunman knows of what he speaks, or so it has always seemed to me.

I don't see how a cancer cure is affected by something over there.

A bumpy ride ahead is more likely now for the next several months.
Save dry powder. It will come in very handy.
Sounds cryptic, but tje axis of evil is using the playbook to incite the Middle East and prolong uncertainty and anxiety.

I held and missed a very nice score. Still up and waiting.

Gopher shared a short article with me and asked that I share it here (some guy named Warren Buffett). I think the message is timely for some of us (definitely me) who get frustrated that the stock price isn't always in line with our fundamental thinking about any particular company that we find ourselves invested in. Thanks Gopher.

https://www.msn.com/en-us/money/savingandinvesting/warren-buffett-criticizes-stock-market-forecasters-make-fortune-tellers-look-good-labels-them-poison-to-be-kept-locked-up/ar-BB1lHZsX?ocid=msedgntp&pc=SMTS&cvid=a5158db669ed48ec80ca132d1902730c&ei=97

It might be a little sales pitchy, but there's some meat in there as well.

Good luck to the longs.

I would suggest not measuring yourself against perfection (buying at the low and selling at the high). It will drive you crazy. The only points that matter is when you buy and when you sell... ignore the lower lows and higher highs in between. If you made a good return from when you bought to when you sold, it was a good trade/investment.

need this to move back up. On paper I am down big time since the high.

Onward and upward. :)

We shall see. I am hoping this is turning back up. This is down like 40% from the recent high. Being retired for many years I am having 2nd thoughts about not selling around $15.

I think those are driven my big "buy/sell at close" orders that come mostly from mutual funds that had big redemption orders coming in that day. They need to raise funds so sell using "at the close" orders. I think these can also come from hedge funds that do day trading and want to close their position overnight.

Surfkast, I don't think it was a "dump". It looks more like an accumulation of smaller purchases that was delivered to a buyer at the end of the day and/or in the after-hours. Might be a fund accumulating again, it might be a short allowing the MM to accumulate during the day without chasing shares and then delivering after hours, it might just be a private customer with the same deal.

It certainly doesn't look like a single position being sold off or I would expect to see the price down even more than what we got today which was in line with the overall sector. Iovance seemed to actually hold up just a bit better than is typical on a down day like today.

The analysts' target prices are for Iovance over the next year, not the next week or even the next month. We've got to see earnings in the Q2, Q3, and maybe even in Q4 before we really see some upside (meaning something over $20) unless the overall sector turns positive again which will float all boats.

Iovance got a nice bump post approval but then got stuck with the overall sector which has been nothing but down since the high back on Feb 28th. Look at the charts and it becomes very obvious what's been happening. No news means no support when the market turns negative, but IOVA is still trading higher relative to the sector post-approval then it was pre-approval.

My explanation is somewhat lacking, but I hope I'm making the point that nothing seems unusual with that large block trading hands today.

The entire block of 1.6 million shares along with another 400K block traded at $11.89 in the after-hours which seems to fit with my explanation.

IMHO

Looks like someone dumped a big block today. Why if this has so many buy recommendations?

Whats the 1.6m trade?

Feb 16, 2024 day of FDA approval for Amtagvi, high for IOVA was $10.44. (news came out late on a Friday which dulled the initial price response).

First full trading day post approval IOVA high was $13.41, and XBI high was $93.84.

Feb 28, XBI hit it's one year high at $103.52 the same day that IOVA hit it's high of $18.33.

Today XBI is currently $87.55, down 15.4% from it's recent high and IOVA is currently $12.05, down 34.3% from it's high on the same day that XBI hit it's one year high.

IOVA is trading 2-3x XBI (that's the correlation).

It's been said by many of us who are bullish on Iovance that this is not a short term play. Revenues will drive price, the price will not run-up significantly until such information is verified or additional good news comes in on other items such as foreign market approvals, positive trials and PDUFA dates being established for other TIL therapies for other solid tumor cancers.

Of course, a buyout at any time is possible, but more likely after a few Q's of reported earnings from Amtagvi.

IMHO

Thankfully it appears Badger is spot on with the Middle East issues this past weekend.
Luckily not a 9-11 outcome for Israel, a huge shoutout to our friends in the region. What a hot mess this region is day in & day out.
For now, As Badger said its Middle East 101 & we should luckily get past a market meltdown like we had in the 9-11 debacle & such a huge loss of American lives.

Stay Strong Longs, Much Brighter Days Lie Ahead!
#CureCancer

We are still at 33 approved ATCs. I do think this will be back-loaded because of the time commitment for training that is required to become an approved ATC.

Slow down, MNGopher. These are all measured responses with intent to show force without a likelihood of much damage. It could escalate, but it will more than likely just be business as usual in the Middle East (as sad as that may be). When you announce what you're going to do as Iran did, the intention is more of a warning and retribution as opposed to all out war. It's a dangerous game to play, but it's not that unusual in that part of the world.

Agreed, it does add volatility to the markets, but just how much is hard to say. This is Middle East 101 to give it a college class moniker.

My hope is that our friends and family over there stay safe.

Badgerkid

Well everyone, the markets will be in turmoil more then before
Oil prices will spike up quickly & the sell off begins on Monday
In my opinion.
Buy what should be a major meltdown, 10-20% if its like 9-11 was.
We may see 9-10 like I thought IF this happened.
Will present a great “timely” buying opportunity before earnings.
Good Luck & Hold Your Shares & Don’t Panic.
#CureCancer

Iran’s drone attack against Israel has begun, per news alert just received.

For me, nothing has changed since the approval and lifting of the halt on the NSCLC trial, so my intrinsic value price target has not changed. The next catalyst will be patient starts reported at Q1 ER.

In regards to being a good buy here, I generally will not increase my cost basis unless there is new facts that emerge (doing so has cost me dearly in the past). I will add exposure specifically for upcoming catalysts by using the options market. I generally try to use structures that limit premium outlay though.

Still rated a buy? Good news on Monday to stop this from drifting down any further?

Just a reminder, the reason we want Iovance to succeed is not only because we'll do very well with our investment, but there's the human factor of improved health and lives well lived. Good luck. Check out Toni's story on the website if you need a refresher on Amtagvi and that human component.

https://www.amtagvi.com/

https://vimeo.com/amtagvi (Toni's story)

Good luck to the longs.

I wanted to clarify why I thought 9-10 is in play in the next 1-4 weeks before 1st Qtr report.
Geopolitical events coming soon in the Middle East, may set off a downward spiral like 9-11 did.
If Israel & Iran literally go “toe to toe”
Bombing each other n their respective interests, we could see 9-10.
Otherwise, Personally I’ve stated before the “Floor” to me has been $12.50
Based on Insiders buying at these price points months ago.
Good Luck & hold onto your positions.
Whatever Macro events affect us, its NOT Iovance as a company & Amtagvi as a treatment for Cancer Patients.
#CureCancer

MNGopher, I think you're low guesses exceed what all of the options and insiders are telling us. We're seeing slow acquisition right now regardless the overall market sentiment. The overall market would really have to tank for those levels IMHO. I think today's action is the typical overreaction to news that was already known. Lemmings! Interest rate hikes. Interest rate reductions. Hold those rates. Seems like a shell game at times, doesn't it?

The reasons to own IOVA haven't changed, the share price has. Seemingly painful in the short term, but I suspect we'll all be happy by this time next year (or sooner).

It wasn't that long ago I couldn't wait for us to get up to this current price. After approval, others said that this current price was possible due to the softening demand and the departure of the hot money. Those same people said they'll be adding once again if the stock price came back down to this price point. Looks like they were correct and I suspect they and others will be adding more aggressively now that it has. I may not have enough powder left for a big bang just yet, but I will add a few more shares at these levels.

Let's see what the next few Q's bring.

Good luck to the longs.

IMHO

Wednesday Bloodbath in BioTech
LABU & XBI getting slaughtered after hot CPI this morning.
Inflation battle is far from over & The Fed is now losing the battle.
Interest Rates will possibly rise again n again.
Interest Rate cuts Wall Street was expecting this year look like its in 2025, not in 2024.
Buckle Up Longs, We are headed straight down possibly between 9 & 10.
Looks ugly to me on the short term, but good/great news will send us soaring upwards after Q-1 Report n hopefully good Q-2 Forward Guidance.
#CureCancer

Don't expect it with share price dropping from $14.82 on March 28th. too $13.15 now, unless the price rises above $14.82 before April 15th.

3/28/2024 Short interest report: now 46.38 million shares short, only slightly down from 47.43 million. FWIW

I suspect that number will drop a bit more for the 4/15/24 report.

Allison was one of the investigative physicians while at NY MSK so if anybody would not need additional training, it would be her. I think that they need to provide the training purely for quality control and to make sure everyone knows the approved protocol, which may be a bit different than that used during the trials.

Did not see my previous post so I re-wrote... sorry for the redundancy.

I just re-listened to the Allison Betof-Warner video with AIM. At the 33 minute mark, she discusses payers and how Medicare approved within hours of the submission, but she also notes that other payers (plural) are also covering but may take some assistance from providers and that she had actually just finished one earlier. The video was posted on 3/14 so seems to be more than a handful from Stanford alone. Given that the treating physicians are required to put in 200-300 hours to become an ATC, I would think that treating physicians in other ATCs would be similarly supportive of recommending this treatment.

GMH, do we know if those 300 hours of training are independent of other training? If a new Amtagvi ATC has already been approved by other companies as an ATC for administering CAR-T or some similar therapy/treatment, would they not already have a significant amount of the necessary training? I truly don't know the answer to this but having sat with friends and family at various treatment centers, there's a lot of training that is necessary but training that may be redundant for any number of meds, etc thereby not requiring a repeat of training that has already been conducted (a transfer credit so to speak).

Just thinking out loud on this one.

I was just re-listening to the AIM video with Allison Betof-Warner. Interesting to note at the 33 minute mark where she discusses reimbursement and payers. Specifically, the ease at which Medicare approved the treatment (45% of patients) as well as her discussion that "the discussion with each payer is different" implying engagement with multiple commercial insurers. She also said patient advocacy may be needed and she was "working with one insurer on that earlier today."

This video was posted on 3/14 (30 post approval), but it sounds like Stanford had at least a handful of patients in process at that time. I know Allison was an investigator in the trial and has been a big proponent of TIL approval. I just hope we have similar people in the other ATCs. Given that it takes 200-300 hours of training by the physician to become an approved ATC, it is not a small investment so the physicians should be supportive of the treatment. Its not like a phama rep coming in with a brochure trying to get the physician to switch preferred drug percriptions.

A few items of note regarding some of the larger positions:

Perceptive Advisors holds 19.2 million shares with an avg cost of 12.94, Blackrock has 19.1 million with an avg cost of 10.07, State Street holds 16.4 million shares with an avg cost 12.50, and Avoro holds 6.7 mil with an avg cost of 16.58.

Additional increases did occur after approval and there doesn't seem to be any rush for the exits.

Good luck to the longs.

Agree with everything you stated. I am reluctant to add more because I generally have not done well when raising my cost basis. I am hoping for break-even earlier than end of 2025 (but I can be overly optimistic at times). I think NSCLC will continue to progress well, especially with the early data on the EGFRwt subgroup. In biotech, everyone wants daily readouts, but it often becomes a long waiting game and people lose interest and move on until the next "surprise" catalyst.

I’ve been investing in small biotechs for a long time and had predicted we may see $12-13 range before we see $20 plus. I plan to load up at these levels and trust the company leadership will exceed expectations with initial ramp up and point to a revenue trajectory which supports breakeven by end of 2025.
Also, I trust the company to achieve positive results with confirmatory trial for metastatic melanoma. Success with NSCLC study will be icing on the cake. Thanks all for sharing your thoughts and progress updates.

Here is a link with recent (2018-2023) Biotech buyouts and premiums paid. Once you get into the MC size that IOVA is currently, the premium is around 75%-100% of previous close price, so we would be looking at a buyout price of $25-$28. I think that may be a fair price for MM, but the other indications are worth as much, if not more due to TAM. I am willing to wait, at least until mNSCLC data comes out. If we can get approval, even if limited to EGRFwt where we are seeing the greatest efficacy (similar to CAR-T), that could easily generate $2-3B in annual revenue in 3-5 years. I am no spring chicken, but I can wait that out (as long as the data continues to come in favorably of course) and will take a 10x (and go it alone) then vs a 2x now.

https://www.biopharmadive.com/news/biotech-pharma-deals-merger-acquisitions-tracker/604262/

No doubt Badger Big BioPharm needs to buy Iovance before the price gets very expensive.

Pfizer stated publicly they moved away from their Pill Based strategy & 9 year exclusive’s to the new Immunotherapy based Pfizer platform to capitalize on the 14 year exclusive & Badger mentioned in am earlier post an additional 4 yr exclusive for Amtagvi. That put us to 2042 in exclusive protection.

Imagine the new indications that will be approved & these long term exclusivities are the KEY to big BioPharm.

The Buyout most likely occurs prior to NSCLC & Cervical are approved, which for us investors we hope for a triple figure cash/stock shares buyout if this occurs.

Time will tell….
#CureCancer

Regarding the links for posted articles - just a heads up, if you click on the links to the previously listed articles, your first click may give you the full article - read it or find a way to copy it. The second try for me led to a snippet of the article along with a sales pitch.

Sorry, fair warning, but I should have known that there's no free lunch with these publications.

The obvious point is that Iovance's patents and the length of their exclusivity may be just what some other companies need to bolster their income stream.

IMHO of course.

Why Iovance patents may be worth more than what we give them credit for - Barron's article: "Big Pharma Stocks Need a Rethink. Investors Keep Making the Same Mistake. Pfizer’s patent expirations are great for humanity but terrible for investors. It’s a common story across the pharmaceutical industry." By Josh Nathan-Kazis, April 04, 2024.

https://www.barrons.com/articles/big-pharma-stocks-investors-mistakes-90e3c575

Some food for thought while we go golfing, bowling, or in my case - going to my real job (I thought that was funny).

The article was fully available on my first visit, but it's now limited by a sale's pitch. Wish I would have copied it and shared it in full. If anyone can provide a link to the full text, please share. The article has a lot of good detail.

FWIW, great NCAA final for women's basketball, even though I was rooting for the Hawkeyes (this time, I am a Badger after all).

Badgerkid

Here's another brief summary regarding patent cliffs:

https://thehealthcaretechnologyreport.com/the-looming-patent-cliff-big-pharma-giants-brace-for-fall/#:~:text=Big%20pharmaceutical%20companies%2C%20including%20industry,dollars%20in%20sales%20at%20risk.

You are correct, Warren & Charlie dont invest in Biotech as far as I know.
But yes, go away play golf, bowl or whatever you like to do like watch the Iowa Hawkeyes Women in todays NCAA Championship, Good Luck!
The message resonates the same, now we sit n patiently wait, financially all we do is add shares & wait & relax
Day to day ups n downs are market induced reactions/ Manipulations, etc
We wait on solid news to build out our long term strategy.
#CureCancer

I don't think either Buffet or Munger would ever invest in the biotech space for that reason. You do need to stay on top of developments (which is why I think, if you do the homework, you can pick the winners in this space as well as other small caps), but it does take work. The problem is that there is no sense in updating the models if nothing changes (no new data). Daily stock price action means nothing, but somehow it makes people nervous. My problem is that I am looking for any little tidbit of data, but in all likelihood, I could/should just go away until Q1 ER update and I wouldn't miss a thing.

Hawkeye, Charlie Munger one of my favorite investment gurus I follow, (Charlie passed recently) would comment on your watching the paint dry post.
He would say More often then not, U Invest in Good Companies (Buffett too) at a Fair Price & then do nothing but wait.
Patience is what creates great wealth, not the buying & selling.
My personal opinion is to add shares on the dips the whole way through the process & Hold & Wait For The Inevitable Buyout Offer Wayne cannot refu$e.
#CureCancer

I think I am watching this too closely which is part of the problem. With no new data emerging, it is really just watching the leaves on the tree blow in the wind.

Good thing is that the weather here is good enough so I can start to go play golf and do other things outside, so will be doing less "watching the paint dry". Spend a couple hours in the AM doing some updates and then letting all my positions percolate.

To that point of drifting with the sector:

XBI down ~4.5% on the week, IOVA down 8% on the week. The correlation persists with IOVA trading around 2-3x XBI on the daily, weekly, and now monthly. Over the last month, IOVA was down 19.6% with the XBI down 9.6%. Iova is just riding the wave of the sector with a little more volatility. IOVA may get a little break free moment with the guidance for Q2 at the Q1 call. Until then, there's nothing to really fear, but nothing to move the needle just yet either. It'll be the numbers at the end of this year that will tell us the story of just how smart we all were with our investment in Iovance. Until then, more up days than down in the sector sure would be nice if this correlation holds true.

I contend that the Iovance team is performing admirably (even though many of us would like to get weekly updates). The three healthcare conference chats that took place over the past month provided many good insights, but they were careful not to give guidance as such. Still, there was a lot of meat to their messages.

I'm in for the long haul. IOVA will have many up days that break free from the sector funds as more clarity on earnings becomes evident.

Good luck to the longs. Have a great weekend. IMHO as always.

Badgerkid

I do not rely on analysts' estimates as they can be all over the place and updated infrequently. I build out my own valuation model (especially in the biotech space). This allows me to update my intrinsic value as new facts emerge. Last updated facts we have is the Approval and lifting of the NSCLC halt. Since then, nothing has changed. Looking forward to next ER when we will probably get patient starts, which will allow me to compare my estimates vs actuals and adjust accordingly. Until then, it is as Badger said, we drift with the sector.